User fees stuck in neutral, (sidebar)

There is no question that ultimately both the U.S. Food & Drug Administration and the packaging business would prefer to have a new 120-day approval program funded by reasonable industry-user fees. That would be a much more dependable way--compared to the politically uncertain and torturous congressional appropriations process--to ensure that $6 million was available annually. Moreover, the user-fee program currently in place for new pharmaceuticals has been a fairly resounding success. Everyone understands no user fee will be in place by Oct. 1, 1999. What is going on now, then, is a tripartite negotiation between the FDA, industry and Congress in an effort to lay the groundwork. Donna Shalala, the secretary of the Department of Health and Human Services (HHS), where the FDA is housed, sent House Speaker Rep. Dennis Hastert (R-IL) a bill in early spring 1999 that establishes user fees for indirect additives, direct additives and medical devices. The indirect additive fees are arrayed in three levels: $5ꯠ for notifications for the least troublesome chemicals, $20ꯠ for chemicals that may be of more concern, and $40ꯠ for chemicals of most concern. Chemical suppliers and packaging manufacturers seem to be okay with those fees as long as they lead to faster approval of indirect additives. Sergio Galeano, manager of environmental product policy and assurance at Georgia Pacific Corp. (Atlanta, GA), says, "The fees are not the issue as long as the approval system is accelerated." GP manufactures corrugated packaging, 30% of which goes to the food industry. The company also has a $1 billion/year chemicals division, which supplies GP packaging and other manufacturers. However, no Democrat or Republican had agreed to introduce the Shalala bill by July, as this is being written. That is not a good sign. Although user fees have worked well for the drug manufacturers, neither the medical device nor grocery industries have been overly enthusiastic about the idea. Brian Sansoni, spokesman for the Grocery Manufacturers of America (GMA), says his association supports the notion of user fees but acknowledges that there is disagreement between GMA, the FDA and Congress over how the program should be structured. Sansoni says his group would like to see an agreement reached as quickly as possible. "But it is not an easy mountain to climb," he adds. Given the very "iffy" prospects for a three-pronged bill, packaging manufacturers would like to see a narrow "indirect additives" bill introduced and passed. With that in mind, members of the Society of the Plastics Industry (SPI) met with FDA officials on May 26. The objective was to get the FDA to agree to changes in the fee structure proposed by Shalala so that the FDA and industry could agree on a single indirect additives bill. This could fly through Congress without being weighted down politically by medical device and direct additive user fees. Ralph Simmons, an attorney at Keller & Heckman, the firm that represents the SPI, film and chemical suppliers, says the industry wants to see a four-tier fee system. The bottom rung would be a $2ꯠ fee for "me-too" chemicals, those chemicals whose base structure is similar to a chemical for which the FDA had already received a notification. Tiers 2, 3 and 4 would basically correspond to Shalala's 1, 2 and 3, except the fees for each would be lower than the $5ꯠ, $20ꯠ and $40ꯠ she proposed. Simmons would not say how much lower. But he states that the SPI/industry fee structure would raise the same $6 million the FDA says it needs to get the indirect additive approval program off the ground.